EfficacyPhase 1NCT07130617
Evaluation of the Efficacy and Safety of Megestrol Acetate in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
A Phase 1 study testing Low dose of Megestrol Acetate Oral Suspension combined with standard therapy, Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy and High dose of Megestrol Acetate Oral Suspension combined with standard therapy in people with Efficacy and Safety, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy in Malignant Solid Tumor Patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Efficacy, Safety, Megestrol Acetate
- What is being tested?
- Low dose of Megestrol Acetate Oral Suspension combined with standard therapy, Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy and High dose of Megestrol Acetate Oral Suspension combined with standard therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2025to 31 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, regardless of sex
- Histologically or cytologically confirmed lung cancer
- Expected survival ≥ 3 months
- Female subjects of childbearing potential must have negative serum pregnancy test within 72 hours prior to randomization and must be non-lactating
- Capable of comprehending and willingly providing signed informed consent form (ICF), and adhering to study requirements/restrictions Exclusion Criteria
- 1. Received or scheduled to receive concurrent radiotherapy within 7 days prior to enrollment through Day 1-8 of treatment 2. Systemic corticosteroid therapy or sedating antihistamines within 7 days prior to enrollment 3. Poorly controlled serous cavity effusions (pleural/peritoneal/pericardial) 4. Severe cardiovascular diseases within 3 months prior to enrollment 5. Participation in other clinical trials within 30 days prior to enrollment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Li Zhang, +86 20-87343458, zhangli@sysucc.org.cn
About this study
Official title: A Phase Ib, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Clinical Study Evaluating the Efficacy and Safety of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
To evaluate the efficacy of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy in Malignant Solid Tumor Patients
Read the detailed description
This multicenter, randomized, double-blind, placebo-controlled parallel-group study evaluates the efficacy, safety, and pharmacokinetic profile of megestrol acetate oral suspension in preventing nausea and vomiting induced by highly emetogenic chemotherapy. The trial plans to enroll 132 chemotherapy-naive malignant solid tumor patients scheduled to undergo initial single-day highly emetogenic chemotherapy regimens.
- Conditions
- Efficacy, Safety, Megestrol Acetate, Adult Subject
- Being tested
- Low dose of Megestrol Acetate Oral Suspension combined with standard therapy, Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy, High dose of Megestrol Acetate Oral Suspension combined with standard therapy, Megestrol Acetate Oral Suspension Placebo combined with standard therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of Megestrol Acetate Oral Suspension combined with standard therapyDrug
A single dose of 312.5 mg/day, administered once daily (QD) for 7 consecutive days.
Medium dose of Megestrol Acetate Oral Suspension combined with standard therapyDrug
A single dose of 625 mg/day, administered once daily (QD) for 7 consecutive days.
High dose of Megestrol Acetate Oral Suspension combined with standard therapyDrug
A single dose of 937.5 mg/day, administered once daily (QD) for 7 consecutive days.
Megestrol Acetate Oral Suspension Placebo combined with standard therapyDrug
A single dose of 5 mL/day, administered once daily (QD) for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Low dose of Megestrol Acetate Oral Suspension | Experimental | Not described Receives: Drug: Low dose of Megestrol Acetate Oral Suspension combined with standard therapy |
| Medium dose of Megestrol Acetate Oral Suspension | Experimental | Not described Receives: Drug: Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy |
| High dose of Megestrol Acetate Oral Suspension | Experimental | Not described Receives: Drug: High dose of Megestrol Acetate Oral Suspension combined with standard therapy |
| Megestrol Acetate Oral Suspension Placebo | Active comparator | Not described Receives: Drug: Megestrol Acetate Oral Suspension Placebo combined with standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Experiencing No Nausea During 0-168 Hours After Initiation of the First Chemotherapy Cycle
Measured: From 0 to 168 Hours After Initiation of Chemotherapy
Proportion of Subjects Experiencing No Nausea During 0-120 Hours After Initiation of the First Chemotherapy Cycle
Measured: From 0 to 120 Hours After Initiation of Chemotherapy
Secondary outcomes (1)
Proportion of Subjects Achieving Complete Response (No significant nausea, No vomiting, etc. ) in the Acute, Delayed, Extended Delayed, 0-120 h, and 0-168 h Phases During the First Chemotherapy Cycle
Measured: From 0 to 168 Hours After Initiation of Chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start29 Sep 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EfficacyStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, PHD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130617
- Sponsor's protocol ID
- GenSci158-101
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Clinical Study Evaluating the Efficacy and Safety of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT07130617
- Acronym / sponsor ID
- GenSci158-101
- Conditions
- Efficacy, Safety, Megestrol Acetate, Adult Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy in Malignant Solid Tumor Patients
Detailed description
This multicenter, randomized, double-blind, placebo-controlled parallel-group study evaluates the efficacy, safety, and pharmacokinetic profile of megestrol acetate oral suspension in preventing nausea and vomiting induced by highly emetogenic chemotherapy. The trial plans to enroll 132 chemotherapy-naive malignant solid tumor patients scheduled to undergo initial single-day highly emetogenic chemotherapy regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose of Megestrol Acetate Oral Suspension | Experimental | Drug: Low dose of Megestrol Acetate Oral Suspension combined with standard therapy |
| Medium dose of Megestrol Acetate Oral Suspension | Experimental | Drug: Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy |
| High dose of Megestrol Acetate Oral Suspension | Experimental | Drug: High dose of Megestrol Acetate Oral Suspension combined with standard therapy |
| Megestrol Acetate Oral Suspension Placebo | Active comparator | Drug: Megestrol Acetate Oral Suspension Placebo combined with standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years, regardless of sex
- Histologically or cytologically confirmed lung cancer
- Expected survival ≥ 3 months
- Female subjects of childbearing potential must have negative serum pregnancy test within 72 hours prior to randomization and must be non-lactating
- Capable of comprehending and willingly providing signed informed consent form (ICF), and adhering to study requirements/restrictions Exclusion Criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose of Megestrol Acetate Oral Suspension combined with standard therapyA single dose of 312.5 mg/day, administered once daily (QD) for 7 consecutive days. | Drug | Low dose of Megestrol Acetate Oral Suspension |
| Medium dose of Megestrol Acetate Oral Suspension combined with standard therapyA single dose of 625 mg/day, administered once daily (QD) for 7 consecutive days. | Drug | Medium dose of Megestrol Acetate Oral Suspension |
| High dose of Megestrol Acetate Oral Suspension combined with standard therapyA single dose of 937.5 mg/day, administered once daily (QD) for 7 consecutive days. | Drug | High dose of Megestrol Acetate Oral Suspension |
| Megestrol Acetate Oral Suspension Placebo combined with standard therapyA single dose of 5 mL/day, administered once daily (QD) for 7 consecutive days. | Drug | Megestrol Acetate Oral Suspension Placebo |
Primary outcome
Proportion of Subjects Experiencing No Nausea During 0-168 Hours After Initiation of the First Chemotherapy Cycle
Time frame: From 0 to 168 Hours After Initiation of Chemotherapy
Proportion of Subjects Experiencing No Nausea During 0-120 Hours After Initiation of the First Chemotherapy Cycle
Time frame: From 0 to 120 Hours After Initiation of Chemotherapy
1 secondary outcome
Proportion of Subjects Achieving Complete Response (No significant nausea, No vomiting, etc. ) in the Acute, Delayed, Extended Delayed, 0-120 h, and 0-168 h Phases During the First Chemotherapy Cycle
Time frame: From 0 to 168 Hours After Initiation of Chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Zhang, PHD principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose of Megestrol Acetate Oral Suspension combined with standard therapy, Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy and High dose of Megestrol Acetate Oral Suspension combined with standard therapy in people with Efficacy and Safety, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, PHD (+86 20-87343458, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Experiencing No Nausea During 0-168 Hours After Initiation of the First Chemotherapy Cycle (time frame: From 0 to 168 Hours After Initiation of Chemotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.